Overview
The KONA product line is a project of Oxigraf, Inc. Oxigraf is an electrical manufacturing company located in the heart of Silicon Valley, the epicenter of “high tech”. We occupy a 5000 square foot facility in Sunnyvale, California, which hosts both office space and an assembly floor. A complete engineering and support team is available in-house to work with customers and provide continuous product improvements and developments.
Our team includes employees and consultants with expertise in optomechanical and electronic engineering, software development, quality systems, and manufacturing. Bruce W. McCaul, Ph.D. (President and CEO) has sixteen years of prior experience as CEO in two companies manufacturing laser spectroscopy systems, medical lasers, infrared detectors and noble gas arc lamps.
Oxigraf has a quality management system to meet the needs of its customers and to improve management of the company. The quality system complies with the U.S. Food and Drug Administration regulation 21 CFR Part 820 Quality System, the European quality system standard EN ISO 13485:2012 + EN ISO 13485:2012/AC:2012. It covers the design, production, and servicing of Oxigraf sensors.
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History
In 1990, like many Silicon Valley companies, Oxigraf began in a garage. Since being incorporated in 1996, Oxigraf has grown considerably and is celebrating over fifteen years in the business of making laser gas sensors and instruments. Recent corporate highlights include:
- Oxigraf has delivered the O2N2 OBIGG system for flight test of the fuel tank safety system to several major aviation/aerospace programs since 2005.
- Oxigraf O2iM Oxygen Safety Monitors have been widely adapted in hundreds of facilities since 2004, replacing less reliable electrochemical sensors.
- The Model O2 received clearance for marketing for human use by the FDA under the 510(K) process in 1998. The Model O2Cap adding CO2 measurement was added in 2004.
- Oxigraf O2 and CO2 sensors have been widely adapted by OEM manufacturers of medical respiratory gas monitors to measure breath waveforms, end-tidal gas values, anaerobic threshold, VO2 max, and non-invasive cardiac outputs.
- Oxigraf has performed two Phase I and one Phase II SBIR contracts for the U.S. Air Force and NASA developing sensors for aviator breathing gas generating systems.
- Oxigraf performed manufacturing and quality engineering services for the ORCA Diagnostic, Inc cardiopulmonary stress test analyzer leading to UL, CSA, and CE approvals in 2000. The ORCA analyzer incorporates an X2004 Oxigraf sensor. Since 2002, Oxigraf has been the exclusive distributor for the ORCA system and continues to service and support these products today.